Senior manufacturing engineer Ryan Fuhr said the projects started in 2009, when an existing client asked about a new line of Animal Derived Component Free products.

“We’re used to making parts for the medical industry and cleaner molding, but making sure it was ADCF was a new requirement,” Fuhr said in a telephone interview.

For plastics, animal-derived ingredients are most common in release agents, which can be derived from bovine tallow.

In order to certify that its products are ADCF, the Circle Pines, Minn.-based had to make sure that all the resins used, and the molded component, did not come into contact with any non-ADCF item, such as a bag, hose or tub.

“We had to look at how it was delivered,” Fuhr said. “What do we have to change to handle the additional complexities?”

Advanced Molding designed a system and a manufacturing cell to make products for the life-sciences company, which Fuhr declined to identify.

The qualification process started in 2010. Fuhr said it included plenty of paperwork as well as great scrutiny in the way the company handled resins and products.

“You can’t really test for ADCF. You have to bring in ADCF resins and make sure that it is not contaminated in any way,” Fuhr said.

The product also needed to be free of latex and bisphenol A, and put together under USP Class IV designations.

In the past, the customer would wash purchased molded components prior to their use in downstream processes, but this project also included a “no wash” requirement. This meant more stringent controls along the process.

Advanced Molding’s solution included a dedicated clean room setup with a work cell that included the molding equipment, clean room air flow and part handling equipment that could do everything with minimal exposure to human operators.

Fuhr said the project was challenging in the breadth of scope of what had to be examined to make absolutely sure that all requirements were met. Making ADCF products is a niche market that Advanced Molding now can handle.

Advanced Molding Technologies was formed in 1999. It has about 100 employees and operates out of 46,000-square-foot facility with Class 10,000 and 100,000 clean room space for molding and assembly. It has injection molding machines ranging from 20-500 tons of clamping force.

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